| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
W/L 53-11
August 12, 2011
Mr. Gustavo Delgadillo, President
GD Designs, Inc.
2511 W. La Palma Avenue, Unit H
Anaheim, CA 92801
Dear Mr. Delgadillo:
During an inspection of your firm located in Anaheim, California from February 16, 2011, through March 29, 2011 an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the TherOzone T-8000. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. 321(h)], this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed that this device is adulterated within the meaning of section 501(h) of the Act [21 U.S. C. § 351(h)], in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820.
We received your responses to the Form FDA 483 dated April 10, 2011 and Apri1 27, 2011 concerning our investigator's observations noted on the Form FDA 483 (FDA 483) List of Inspectional Observations that was issued to you. We address your responses below in relation to each of the noted violations. These violations include, but are not limited to the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, your firm has not established procedures for implementing corrective and preventive action.
The adequacy of your responses dated April 10, 2011, and April 27, 2011, cannot be determined at this time. In these responses you committed to cease manufacturing the TherOzone devices.
You stated your firm was in the process of developing and implementing a "compliant Quality System" which will be in place by October, 2011, at which point your firm will resume the manufacturing of new devices for TherOzone.
2. Failure to establish and maintain procedures to control the design of the device, as required by 21 CFR 820.30(a). For example, your firm has no design control procedures, and changes have been made to the TherOzone product line including changes to the (b)(4) changes to the (b)(4) changes in the design of the (b)(4), different (b)(4) utilized, and other upgrades and updating of components in the TherOzone devices. There were no procedures provided during the inspection to distinguish what changes are to be communicated to TherOzone' s President or other members of the specifications development team of the TherOzone Units, the type of review that takes place when certain designs are made, and if further approval from the TherOzone President or member of specifications development team is required when certain changes are made. There is no document to distinguish what are "small design changes" and what are "major design changes." None of these changes have been controlled using established design control procedures.
The adequacy of your responses dated April 10, 2011, and April 27, 2011, cannot be determined at this time. In these responses you committed to cease manufacturing the TherOzone devices. You stated your firm was in the process of developing and implementing a "compliant Quality System" which will be in place by October, 2011, at which point your firm will resume the manufacturing of new devices for TherOzone.
3. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). For example, your firm has not established acceptance procedures for incoming components. There is no documentation referencing any kind of incoming oversight of components and raw materials to insure that they are acceptable for use in the manufacture/assembly of the TherOzone Units.
The adequacy of your responses dated April 10, 2011, and April 27, 2011, cannot be determined at this time. In these responses your firm committed to cease manufacturing the TherOzone devices. You stated your firm was in the process of developing and implementing a "compliant Quality System" which will be in place by October, 2011, at which point your firm will resume the manufacturing of new devices for TherOzone.
4. Failure to establish procedures for conducting quality audits, as required by 21 CFR 820.22. For example, your firm has not established procedures for conducting quality audits and has not performed any audits relating to evaluation of product quality or to ensure the effectiveness of the quality system.
The adequacy of your responses dated April 10, 2011, and April 27, 2011, cannot be determined at this time. In these responses you committed to cease manufacturing the TherOzone devices. You stated your firm was in the process of developing and implementing a "compliant Quality System" which will be in place by October, 2011, at which point your firm will resume the manufacturing of new devices for TherOzone.
5. Failure to ensure that your device history record includes the primary identification label and labeling used for each production lot, as required by 21 CFR 820.184(e). For example, a review of forty three final assembly and inspection reports did not include the primary identification label.
The adequacy of your responses dated April 10, 2011, and April 27, 2011, cannot be determined at this time. In these responses you committed to cease manufacturing the TherOzone devices. You stated your firm was in the process of developing and implementing a "compliant Quality System" which will be in place by October, 2011, at which point your firm will resume the manufacturing of new devices for TherOzone.
6. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm has not established procedures or maintained training records for your employees who perform operations such as assembly, manufacturing, and final product testing of the TherOzone devices.
The adequacy of your responses dated April 10, 2011, and April 27, 2011, cannot be determined at this time. In these responses you committed to cease manufacturing the TherOzone devices. You stated your firm was in the process of developing and implementing a "compliant Quality System" which will be in place by October, 2011, at which point your firm will resume the manufacturing of new devices for TherOzone.
Our inspection also revealed that the TherOzone T-8000 is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k).
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (section 510(p) of the Act (21 U.S.C. 360(p))) during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not fulfilled your annual registration and listing requirements for fiscal year 2011.
Therefore all of your devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 (21 U.S.C. § 360) and were not included in a list required by section 510(j) (21 U.S.C. § 360(j)).
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to:
Mr. Blake Bevill, Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
If you have any questions about the content of this letter please contact Dr. William Vitale, Compliance Officer, at 949-608-2919.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely,
/s/
Alonza E. Cruse
District Director
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